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EGFR-TKI With Chemotherapy in NSCLC Patients With Both EGFR Mutation and BIM Deletion Polymorphism

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ClinicalTrials.gov Identifier: NCT02859077
Recruitment Status : Unknown
Verified August 2016 by Caicun Zhou, Shanghai Pulmonary Hospital, Shanghai, China.
Recruitment status was:  Not yet recruiting
First Posted : August 8, 2016
Last Update Posted : August 9, 2016
Sponsor:
Information provided by (Responsible Party):
Caicun Zhou, Shanghai Pulmonary Hospital, Shanghai, China

Tracking Information
First Submitted Date  ICMJE July 31, 2016
First Posted Date  ICMJE August 8, 2016
Last Update Posted Date August 9, 2016
Study Start Date  ICMJE August 2016
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2016)
Progress Free Survival [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2016)
  • Overall Response Rate [ Time Frame: 1 year ]
  • Overall Survival [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE EGFR-TKI With Chemotherapy in NSCLC Patients With Both EGFR Mutation and BIM Deletion Polymorphism
Official Title  ICMJE EGFR-TKI With Chemotherapy as First Line Treatment in Stage IIIB/IV NSCLC Patients With Both EGFR Mutation and BIM Deletion Polymorphism
Brief Summary BIM deletion polymorphism might be associated with a poor clinical response to EGFR-TKIs in patients who had NSCLC with EGFR mutations. In the study, the investigators want to use EGFR-TKI with chemotherapy as first line treatment in stage IIIB/IV NSCLC patients with both EGFR mutation and BIM deletion polymorphism.
Detailed Description BIM deletion polymorphism was a poor clinical response marker to EGFR-TKIs in NSCLC patients who had EGFR mutations. In the study, the investigators want to use EGFR-TKI with chemotherapy as 1 st treatment in stage IIIB/IV NSCLC patients with both EGFR mutation and BIM deletion polymorphism.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-Small-Cell Lung Cancer
Intervention  ICMJE
  • Drug: EGFR-TKI
    EGFR-TKI (gefitinib)
    Other Name: gefitinib
  • Drug: Chemotherapy(pemetrexed/gemcitabine)
    Chemotherapy (pemetrexed/gemcitabine)
    Other Name: pemetrexed/gemcitabine
  • Drug: Chemotherapy(carboplatin)
    Chemotherapy(carboplatin)
    Other Name: carboplatin
Study Arms  ICMJE Experimental: EGFR-TKI and Chemotherapy
NSCLC patients
Interventions:
  • Drug: EGFR-TKI
  • Drug: Chemotherapy(pemetrexed/gemcitabine)
  • Drug: Chemotherapy(carboplatin)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 3, 2016)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2018
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Signed informed consent Age >=18 years Histologically documented, unresectable, inoperable, locally advanced, recurrent or metastatic Stage IV Non-Small Cell Lung Cancer (NSCLC) A cytologic diagnosis is acceptable (i.e., FNA or pleural fluid cytology) Must have measurable or non-measurable disease Must be able to comply with study and follow-up procedures

Exclusion Criteria:

Small cell, carcinoid, or mixed small cell lung cancer Malignancies within 3 years except for adequately treated carcinoma in situ of -the cervix or basal or squamous cell skin cancer Symptomatic or untreated brain metastases Prior systemic chemotherapy for NSCLC Unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months prior to Day 1, or serious cardiac arrhythmia requiring medication (patients with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia, are eligible) History of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the patient at high risk from treatment complications Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation, or prior surgical procedures affecting absorption Pregnancy or lactation

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02859077
Other Study ID Numbers  ICMJE ShanghaiPH01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: We will share the analysis data.
Responsible Party Caicun Zhou, Shanghai Pulmonary Hospital, Shanghai, China
Study Sponsor  ICMJE Shanghai Pulmonary Hospital, Shanghai, China
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Caicun Zhou, MD, PHD Shanghai Pulmonary Hospital, Tongji University
PRS Account Shanghai Pulmonary Hospital, Shanghai, China
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP